Blog
RSS FeedPosted by Michael Wonder on 21 Feb 2023
US FDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review
21 February 2023 - US FDA has set an action date for August 2023. ...
Posted by Michael Wonder on 21 Feb 2023
Alnylam announces US FDA acceptance of supplemental new drug application for Onpattro (patisiran) for the treatment of the cardiomyopathy of ATTR amyloidosis
21 February 2023 - PDUFA date set for 8 October 2023. ...
Posted by Michael Wonder on 21 Feb 2023
Pozelimab (C5 antibody) BLA for treatment of children and adults with ultra-rare CHAPLE disease accepted for FDA priority review
21 February 2023 - If approved, pozelimab would be the first and only treatment for those living with CHAPLE. ...
Posted by Michael Wonder on 21 Feb 2023
FDA accepts Orasis Pharmaceuticals' new drug application for CSF-1 for the treatment of presbyopia
21 February 2023 - Investigational, novel eye drop candidate was assigned PDUFA goal date of 22 October 2023. ...
Posted by Michael Wonder on 20 Feb 2023
FDA accepts Valneva’s chikungunya vaccine license application for priority review
20 February 2023 - Valneva today announced that the US FDA has completed a filing review of its biologics license ...
Posted by Michael Wonder on 20 Feb 2023
Astellas provides update on fezolinetant new drug application in US
20 February 2023 - Astellas Pharma today announced the US FDA notified the company that it is extending the original priority ...
Posted by Michael Wonder on 18 Feb 2023
Pfizer announces positive Talzenna and Xtandi combination data from Phase 3 TALAPRO-2 trial
16 February 2023 - Supplemental new drug application for Talzenna and Xtandi combination granted US FDA priority review. ...
Posted by Michael Wonder on 17 Feb 2023
US FDA accepts for priority review the supplemental new drug application for Merck’s Prevymis for prophylaxis of cytomegalovirus disease in kidney transplant recipients at high risk
17 February 2023 - FDA also accepts a separate supplemental application to extend prophylaxis with Prevymis to 200 days in ...
Posted by Michael Wonder on 17 Feb 2023
Iveric Bio announces FDA accepts new drug application and grants priority review for avacincaptad pegol for the treatment of geographic atrophy
16 February 2023 - PDUFA goal date is 19 August 2023. ...
Posted by Michael Wonder on 16 Feb 2023
Delcath Systems announces new drug application resubmission for Hepzato Kit
14 February 2023 - Delcath Systems announced it submitted a new drug application resubmission to the US FDA for the ...
Posted by Michael Wonder on 15 Feb 2023
Galera announces FDA acceptance and priority review of avasopasem NDA for radiotherapy induced severe oral mucositis
15 February 2023 - PDUFA target date of 9 August 2023. ...
Posted by Michael Wonder on 15 Feb 2023
Henlius announces US FDA acceptance of biologics license application for proposed biosimilar trastuzumab HLX02
14 February 2023 - The first Chinese biosimilar approved in both China and the EU, and potentially to be approved in ...
Posted by Michael Wonder on 14 Feb 2023
NATCO files generic olaparib tablets in US
13 February 2023 - NATCO Pharma announces submission of abbreviated new drug application containing a paragraph IV certification with the ...
Posted by Michael Wonder on 14 Feb 2023
FDA grants 15 June 2023 PDUFA date to Albireo for Bylvay in Alagille syndrome
14 February 2023 - ASSERT study demonstrated efficacy of Bylvay in pruritus, bile acids and sleep with a low drug-related diarrhoea ...
Posted by Michael Wonder on 14 Feb 2023
Mirum Pharmaceuticals submits supplemental new drug application to FDA for Livmarli in patients with cholestatic pruritus in progressive familial intrahepatic cholestasis
14 February 2023 - Submission based on MARCH Phase 3 study with high statistical significance (p<0.0001) between LIVMARLI versus placebo, and ...